The narcotic painkiller Opana ER, has been linked with drug abuse and a spike in injection-related diseases. On July 6, Irish drug manufacturer Endo International gave in to U.S. Food and Drug Administration (FDA) pressure and halted sales of Opana. The action came one month after the agency requested Endo withdraw a reformulated version of Opana (oxymorphone hydrochloride), Law360 reports.
Users have taken to liquefying and injecting the drug due to its being made to resist crushing the pill and snorting it. There has been a “serious outbreak of HIV and hepatitis C,” according to the FDA, because of the rise in users injecting the drug.
Drugmaker Endo said in an announcement, it “continues to believe in the safety, efficacy and favorable benefit-risk profile of Opana.” But it added that, after “careful consideration,” it would abide by the FDA’s request.
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FDA’s Landmark Action
The FDA had never before attempted to stop sales of a prescription opioid because of abuse risks, so this was an important milestone. In 2015, over 30,000 Americans suffered fatal overdoses from abuse of opioids, chiefly prescription painkillers and heroin.
This significant step was also a serious financial blow to Endo. Last year the drug company earned nearly $160 million from Opana sales – almost 14 percent of the company’s revenue, according to Law360.
The FDA has remarked it is examining abuse patterns regarding other opioids and will continue to act when and if it is appropriate. Opana was already facing FDA scrutiny before FDA Commissioner Scott Gottlieb, M.D., took office. “We are facing an opioid epidemic – a public health crisis, and we must take all necessary steps to reduce the scope of opioid misuse and abuse,” said Gottlieb. The Commissioner said they would continue to take regulatory steps when they see situations where an opioid product’s risks outweigh its benefits. A public forum is planned for the near future as part of Gottlieb’s vow to address the opioid crisis.
New Version of Opana
Endo allegedly reformulated Opana for safety reasons. The new version of the drug had the potential to block generics if the FDA discovered that Endo discarded the older version because of safety issues. However, in 2013, the FDA hesitated, and in that hesitation, it cited preliminary evidence suggesting the “troubling possibility that a higher percentage of reformulated Opana ER abuse is via injection than was the case with the original formulation.”
In spite of the problems with Opana’s new version, the FDA says that opioid manufacturers should still make the effort to incorporate abuse-deterrent technology into their drugs. The FDA, found, however, that the “data did not show that the reformulation could be expected to meaningfully reduce abuse.”
Opana was first approved by the FDA in 2006 for the management of moderate-to-severe pain, when a pain reliever, (opioid analgesic) is required for an extended period of time. Endo replaced the original formulation with a new one intended to make the drug resistant to physical or chemical manipulation for abuse by snorting or injecting. The reformulation of Opana ER has been associated with a serious outbreak of HIV and Hepatitis C, as well as cases of a serious blood disorder (thrombotic microangiopathy).
This outbreak of disease is what prompted the FDA to make its decision to request Opana ER’s withdrawal from the market. “When we determined that the product had dangerous unintended consequences, we made a decision to request its withdrawal from the market,” said Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research. “This action will protect the public from further potential for misuse and abuse of this product.”
Attempts to Make Opana Safer
Endo had tried to make it more difficult for addicts to use Opana ER by making it with a coating that made it hard to crush. The medication is intended to release over time, but addicts had been crushing it to get a massive high all at once, reports CNN.
More people died in 2014, from drug overdoses than any other year on record. More than 60 percent of those deaths were associated with an opioid, according to the federal government, reports USA TODAY.
Legal Information Concerning Opana
If you or someone you know has been affected or injured by drugs, you may have valuable legal rights. Parker Waichman LLP personal injury lawyers offer free, no-obligation case evaluations. We urge you to contact our attorneys at 1-800-YOURLAWYER (1-800-968-7529).